85640 Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4849] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Food Allergen 

Labeling and Reporting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing an opportunity for 

public comment on the proposed 

collection of certain information by the 

Agency. Under the Paperwork 

Reduction Act of 1995 (PRA), Federal 

agencies are required to publish notice 

in the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with statutory 

provisions applicable to ingredients 

derived from major food allergens. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

February 6, 2024. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

February 6, 2024. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal:

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2023–N–4849 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Food 

Allergen Labeling and Reporting.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through

Friday, 240–402–7500.

• Confidential Submissions—To

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on the following topics: (1) 

whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 

including whether the information will 

have practical utility; (2) the accuracy of 

FDA’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 


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Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 85641 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Food Allergen Labeling and Reporting 

OMB Control Number 0910–0792— 

Revision 

This information collection helps 

support implementation of statutory 

requirements pertaining to ingredients 

derived from major food allergens. The 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) defines the term ‘‘major 

food allergen’’ (section 201(qq) of the 

FD&C Act (21 U.S.C. 321(qq))) and 

provides that foods are misbranded 

unless they declare the presence of each 

major food allergen on the product label 

using the name of the food source from 

which the major food allergen is derived 

or are exempt from the requirement. 

Under sections 403(w)(6) and (7) of the 

FD&C Act (21 U.S.C. 343(w)(6) and (7)), 

respondents may request an FDA 

determination that an ingredient is 

exempt from the labeling requirement of 

section 403(w)(1) of the FD&C Act. 

Alternatively, an ingredient may 

become exempt through submission of a 

notification containing scientific 

evidence showing that the ingredient 

‘‘does not contain allergenic protein’’ or 

that there has been a previous 

determination through a premarket 

approval process under section 409 of 

the FD&C Act (21 U.S.C. 348) that the 

ingredient ‘‘does not cause an allergic 

response that poses a risk to human 

health’’ (section 403(w)(7) of the FD&C 

Act). 

To assist respondents with the 

information collection in this regard, the 

document entitled ‘‘Guidance for 

Industry: Food Allergen Labeling 

Exemption Petitions and Notifications’’ 

(June 2015), available on our website at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/guidance-industry-foodallergen-labeling-exemption-petitionsand-notifications, communicates 

information we recommend respondents 

include in petitions submitted under 

sections 403(w)(6) and (7) of the FD&C 

Act or notifications submitted under 

section 409 of the FD&C Act. We use the 

information submitted in the petition or 

notification to determine whether the 

ingredient satisfies the criteria of section 

403(w)(6) and (7) of the FD&C Act for 

granting the exemption. The allergen 

information disclosed on the label or 

labeling of a food product benefits 

consumers who purchase that food 

product. Because even small exposure 

to a food allergen can potentially cause 

an adverse reaction, consumers rely 

upon food labeling information to help 

determine their product choices. 

On April 23, 2021, the definition of 

the term major food allergen was 

amended by the Food Allergy Safety, 

Treatment, Education, and Research Act 

of 2021 (FASTER Act) (Pub. L. 117–11) 

to include sesame. Accordingly, we are 

revising the information collection to 

account for burden attributable to 

required declarations and/or associated 

requests for exemption as they pertain 

to foods that include sesame. We issued 

the draft guidance document entitled 

‘‘Questions and Answers Regarding 

Food Allergens, Including the Food 

Allergen Labeling Requirements of the 

Federal Food, Drug, and Cosmetic Act 

(Edition 5)’’ (November 2022), available 

on our website at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents/draft-guidanceindustry-questions-and-answersregarding-food-allergen-labelingedition-5, that once finalized, will 

communicate our current thinking 

regarding the labeling of food allergens, 

including sesame in food products 

regulated under section 403 of the FD&C 

Act. The guidance was issued consistent 

with our good guidance practice 

regulations in 21 CFR 10.115, which 

provide for public comment at any time. 

Description of Respondents: The 

respondents to this collection of 

information are manufacturers and 

packers of packaged foods sold in the 

United States subject to the labeling 

requirements and prohibitions found in 

section 403 of the FD&C Act. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

FD&C Act Section; information collection 

activity 

Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total 

annual 

disclosures 

Average 

burden per 

disclosure 

Total hours Total capital 

costs 

403; review product labeling for compliance with applicable statutory requirements .................................................... 77,500 1 77,500 1 77,500 0

403; redesign/modifications to product labeling for compliance with applicable 

statutory requirements .......................... 775 1 775 16 12,400 $1,414,375 

Total .................................................. ........................ ........................ ........................ ........................ 89,900 1,414,375

1There are no operating and maintenance costs associated with this collection of information. 

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

FD&C Act Section; information collection activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

403(w)(6); petition for exemptions ....................................... 6 1 6 100 600 

403(w)(7); notification submissions ..................................... 6 1 6 68 408 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,008 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Our estimate of the third-party 

disclosure burden associated with food 

allergen labeling under section 

403(w)(1) of the FD&C Act includes the 

time we assume respondents need to 

review the labels of new or reformulated 


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85642 Federal Register / Vol. 88, No. 235 / Friday, December 8, 2023 / Notices 

products for compliance with the 

requirements of section 403(w)(1) of the 

FD&C Act, along with the time needed 

to make any needed modifications to the 

labels of those products. We believe 

firms have already redesigned their 

labels to comply with requirements 

under the Food Allergen Labeling and 

Consumer Protection Act of 2004. 

However, this estimate accounts for 

firms that will redesign their label to 

comply with requirements under the 

FASTER Act. Our estimated reporting 

burden is based on our past experience 

with these submissions. We have 

increased our cumulative estimate by 

12,552 hours and 776 responses 

annually to reflect the inclusion of 

sesame as a major food allergen. 

Dated: December 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–27018 Filed 12–7–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2851] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Time and Extent 

Applications for Nonprescription Drug 

Products 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by January 8, 

2024. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0688. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Time and Extent Applications for 

Nonprescription Drug Products 

OMB Control Number 0910–0688— 

Revision 

I. Background

This information collection supports

certain Agency regulations in part 330 

(21 CFR part 330) regarding over-thecounter (OTC) human drugs and 

associated guidance. Specifically, FDA 

regulations in §§ 330.14 and 330.15 (21 

CFR 330.14 and 330.15) establish 

additional criteria and procedures for 

classifying OTC drugs as generally 

recognized as safe and effective and not 

misbranded. These regulations provide 

that OTC drug products introduced into 

the U.S. market after the OTC drug 

review began in 1972 and OTC drug 

products without any marketing 

experience in the United States can be 

evaluated under the OTC monograph 

system if the conditions (e.g., active 

ingredients) meet certain ‘‘time and 

extent’’ criteria outlined in the 

regulations. The regulations in § 330.14 

allow a sponsor to submit certain 

information to the Agency in a time and 

extent application (TEA) for use to 

determine eligibility of a condition for 

consideration in the OTC monograph 

system. 

We developed the final guidance 

document entitled ‘‘Time and Extent 

Applications for Nonprescription Drug 

Products’’ (September 2011) (available 

from our website at https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/timeand-extent-applicationsnonprescription-drug-products) to assist 

respondents with the information 

collection provisions found in the 

regulations. The guidance was issued 

consistent with our good guidance 

practice regulations at 21 CFR 10.115, 

which provide for comment at any time. 

The guidance explains what information 

an applicant should submit to the 

Agency to request that a drug product be 

included in the OTC drug monograph 

system. The guidance also discusses 

format and content elements, and the 

process for submitting information, 

consistent with the applicable 

regulations. 

II. OTC Monograph Reform in the

Coronavirus Aid, Relief, and Economic

Security Act

The Coronavirus Aid, Relief, and 

Economic Security Act (CARES Act 

(Pub. L. 116–136, Stat. 281)) signed 

March 27, 2020, included provisions 

that govern the way certain OTC drugs 

are regulated in the United States. The 

CARES Act added section 505G to the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 355h), which 

reforms and modernizes the OTC drug 

review process, including establishing 

new procedures for consideration of 

additions or changes to conditions 

covered in OTC monographs. As a result 

of these revised statutory provisions, we 

anticipate no submissions under 

§ 330.14. Our OTC Monographs@FDA

portal (https://dps.fda.gov/omuf)

provides additional information about

OTC monograph drugs and the OTC

drug review process.

Consistent with section 505G(k)(3) of 

the FD&C Act, we plan to withdraw the 

regulations supporting the TEA 

provisions in part 330 and discontinue 

the related guidance document. When 

these actions occur, we will also request 

discontinuation of the information 

collection approved under OMB control 

number 0910–0688. 

In the Federal Register of August 8, 

2023 (88 FR 53497), FDA published a 

60-day notice requesting public

comment on the proposed collection of

information. No comments were

received.

We estimate the burden of this 

collection of information as follows: 


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